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Intrathecal versus Oral Baclofen; Long-term Spasticity, Pain, Sleep, Fatigue and Quality of Life

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Objective: No study has compared outcomes of long-term intrathecal versus oral baclofen therapy for spasticity. This study aimed to compare spasticity levels, pain, sleep, fatigue, and quality of life between individuals receiving treatment with intrathecal versus oral baclofen.

Design: Cross-sectional matched cohort survey study

Setting: Urban academic rehabilitation outpatient clinics

Participants: Adult patients with spasticity, treated with intrathecal or oral baclofen for at least 1 year, matched 1:1 for age, gender, and diagnosis.

Methods: Standardized surveys were administered during clinic appointments or by telephone.

Main Outcome Measures: Surveys included the Penn Spasm Frequency Scale (PSFS), Brief Pain Inventory, Epworth Sleepiness Scale, Fatigue Severity Scale, Life Satisfaction Questionnaire, Diener Satisfaction with Life Scale.

Results:  62 matched subjects were enrolled. The mean (standard deviation (SD)) age was 46 (11) years with a mean duration of intrathecal baclofen or oral baclofen treatment of 11 (6) and 13 (11) years, respectively. There were 40 (64%) males and 22 (36%) females. Primary diagnoses included spinal cord injury (SCI) (n=38), cerebral palsy (n=10), stroke (n=10) and multiple sclerosis (n=4). The mean (SD) dose of intrathecal and oral baclofen at the time of survey were 577 (1429) mcg/day and 86 (50) mg/day, respectively. Patients receiving intrathecal compared to oral baclofen experienced significantly fewer [1.44 (0.92) vs. 2.37 (1.12)] and less severe [1.44 (0.92) vs. 2.16 (0.83)] spasms, respectively as measured by the PSFS (p<0.01; p<0.01). There were no significant differences in pain, sleep, fatigue and quality of life between groups. Subanalysis of patients with SCI mirrored results of the entire study sample, with significant decreases in spasm frequency and severity associated with intrathecal compared to oral baclofen (p<0.01; p<0.01), but no other between group differences. The mean (SD) percent change in dose of oral (21% [33%]) compared to intrathecal (3% [28%]) baclofen was significantly larger two years prior to the date of survey (p=0.02).

Conclusions:  Long-term treatment with intrathecal compared to oral baclofen is associated with reduced spasm frequency and severity as well as greater dose stability. These benefits must be weighted against the risks of internal pump and catheter placement in patients considering intrathecal baclofen therapy.

 

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